MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-14 for AERO C CAGE 5MM INTERBODY DEVICE, 12DX14W PARALLEL 48892050 manufactured by Stryker Spine-us.
[184156671]
Stryker representative reported that when surgeon malleted an aero-c cage 5mm interbody device, 12dx14w parallel into the disc space, the blades were outside of the implant and the implant bent. Surgery was completed with an unknown delay. No adverse consequences or medical intervention were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009617544-2020-00039 |
| MDR Report Key | 9832644 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-14 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RITA KARAN |
| Manufacturer Street | 2 PEARL COURT |
| Manufacturer City | ALLENDALE NJ 07401 |
| Manufacturer Country | US |
| Manufacturer Postal | 07401 |
| Manufacturer Phone | 2017608000 |
| Manufacturer G1 | STRYKER SPINE-FRANCE |
| Manufacturer Street | ZONE INDUSTRIELLE DE MARTICOT |
| Manufacturer City | CESTAS 33610 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 33610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AERO C CAGE 5MM INTERBODY DEVICE, 12DX14W PARALLEL |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL |
| Product Code | ODP |
| Date Received | 2020-03-14 |
| Returned To Mfg | 2020-03-02 |
| Model Number | 48892050 |
| Catalog Number | 48892050 |
| Lot Number | 171879 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SPINE-US |
| Manufacturer Address | 2 PEARL COURT ALLENDALE NJ 07401 US 07401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-14 |